Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Phase 1
Completed
- Conditions
- Non-Hodgkin's LymphomaChronic Lymphocytic LeukemiaHodgkin's LymphomaPeripheral T-Cell Lymphoma
- Interventions
- Registration Number
- NCT01767766
- Lead Sponsor
- TG Therapeutics, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Refractory to or relapsed after at least 1 prior treatment regimen;
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
- At least 18 years of age.
Exclusion Criteria
- Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
- Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
- Known hepatitis B virus, hepatitis C virus or HIV infection;
- Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TGR-1202 TGR-1202 TGR-1202 Daily Oral Dose
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose acceptable for participants 28 days (1 cycle of therapy) To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
- Secondary Outcome Measures
Name Time Method Overall Response Rate Up to 1 year To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202
Trial Locations
- Locations (2)
TG Therapeutics Trial Site
🇺🇸Nashville, Tennessee, United States
TG Therapeutics Investigational Trial Site
🇺🇸Milwaukee, Wisconsin, United States